Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-05-05.
At a glance
Inspections
2
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Apr 2020 – 5 May 2020 | Human Drugs | 483 | View 483 → |
| 12 Feb 2018 – 16 Feb 2018 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
5 May 2020
21 CFR 58.190(a)
Archives: data, documentation, specimens
Cited by Angela Shepas, Sunitha K Rajaram, Mark J Seaton, Lynda L Lanning
5 May 2020
21 CFR 58.35(b)(5)
QAU: authorize deviations from protocols or SOPs
Cited by Angela Shepas, Sunitha K Rajaram, Mark J Seaton, Lynda L Lanning
5 May 2020
21 CFR 58.35(b)(6)
QAU: review final study report
Cited by Angela Shepas, Sunitha K Rajaram, Mark J Seaton, Lynda L Lanning
5 May 2020
21 CFR 58.63(c)
Equipment: maintenance records
Cited by Angela Shepas, Sunitha K Rajaram, Mark J Seaton, Lynda L Lanning
5 May 2020
21 CFR 58.81(a)
SOPs: laboratory methods
Cited by Angela Shepas, Sunitha K Rajaram, Mark J Seaton, Lynda L Lanning
Investigators
FDA investigators tied to this site in the record.
Angela Shepas1 insp.
Sunitha K Rajaram1 insp.
Mark J Seaton1 insp.
Lynda L Lanning1 insp.
Stanley Au1 insp.
Himanshu Gupta1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.190(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.63(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.81(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Alturas Analytics, Inc.'s 2 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat